Introduction and Discussion of IMDRF Personalized Medical Device Regulatory Pathways / 中国医疗器械杂志

OBJECTIVE@#To interpret the key contents of the guidance of Personalized Medical Device Regulatory Pathways issued by the IMDRF, and provide reference for the improvement of China's medical device regulatory system.@*METHODS@#The regulatory requirements of personalized medical devices and point-of-care manufacture of medical device were described respectively, and the feasibility of implementing the regulation of point-of-care manufacture of medical device in China was analyzed.@*RESULTS@#The different regulatory pathways of medical devices produced at point-of-care are feasible and have different regulatory risks.@*CONCLUSIONS@#In combination with the recommendations provided by the IMDRF guidance and the clinical and regulatory realities in China, we should accelerate the improvement of the regulations and supporting documents for point-of-care manufacture of medical device in China.

Regulations for the Manufacture and Control of Live Poliovirus Vaccine: International Experience and China's Path / 中国医学科学杂志(英文版)

The eradication of poliomyelitis is a landmark achievement in the history of public health, providing strong protection for children's health. The introduction of the Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine is a prerequisite and safeguard for the large-scale production and use of domestically produced live poliovirus vaccines, serving as an indispensable component of vaccine safety. This article, based on archival documents, letters, collections of essays, and oral interviews, examines the historical experience of the development of Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine. It contends that the emphasis on localization and the active engagement in international cooperation are critical factors in the swift introduction of Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine.

A clinical application study of digital manufacturing simple intraoral Gothic arch-tracing device in determining the centric relation of complete dentures / 北京大学学报(医学版)

OBJECTIVE@#To verify the consistency between the digital manufacturing simple intraoral Gothic arch-tracing device and the traditional intraoral Gothic arch-tracing device in determining the centric relation of complete dentures restoration.@*METHODS@#Ten outpatients with edentulous jaws were selec-ted, and the centric relation of the patients was determined by digital manufacturing of simple intraoral Gothic arch-tracing device (T1) and traditional intraoral Gothic arch-tracing device (T2); the difference of clinical operation time between the two methods was recorded; the upper and lower edentulous jaw plaster models were scanned with two kinds of centric relation, the Standard Triangle Language (STL) files imported into Geomagic studio software to apply the best fitting of multiple points of the both upper jaw models, the fitted STL files imported into the 3 shape viewer software, and the maximum position deviations of the vertical, labial (buccal) and lingual directions of the mandibular midline area and molar areas in T1 and T2 groups measured. During the clinical complete dentures try-in, we observed whether there was midline deviation in the mouth of T1 group and T2 group, and whether the occlusion of posterior teeth was stable or not.@*RESULTS@#The mean time spent on determining the centric relation of T1 and T2 groups was (41.90±2.64) min, (57.50±2.37) min respectively. Paired t test was conducted in the two groups, P < 0.01 with significant statistical difference; The mean maximum position deviation between T1 group and T2 group of the midline mandibular region in labial lingual direction was (0.32±0.14) mm, that was (0.40±0.23) mm in vertical direction; the mean maximum position deviation of molar area in buccal lingual direction was (0.35±0.23) mm and that was (0.33±0.20) mm in vertical direction. In the vertical and horizontal directions, the maximum position deviation of mandibles between group T1 and group T2 was controlled within 0.5 mm. In the process of clinical complete dentures try-in, there was no deviation from the center line of dentures. There was not warping, swinging and other poor stability phenomena in T1 and T2 groups.@*CONCLUSION@#The digital manufacturing of simple intraoral Gothic arch-tracing device can be used to determine the centric relation of complete dentures, which can not only save time of clinical operation, but also ensure the accuracy of the centric relation.

Research progress on 3D printing in minimally invasive endodontics / 口腔疾病防治

@#Minimally invasive endodontics (MIE) can preserve dental tissue to a greater extent and improve the success rate of endodontics and has thus attracted increasing attention. 3D printing is a technology that is based on a digital model and uses powdered metal, plastic and other materials to construct objects by printing layer by layer. This article reviews the application of 3D printing technology in minimally invasive endodontics to provide a reference for the application of 3D printing technology in clinical minimally invasive endodontics in the future. In recent years, 3D printing technology has been widely used in various professional fields of stomatology, such as maxillofacial surgery, prosthodontics, and orthodontics. Using cone beam computed tomography (CBCT) and oral scanners to obtain accurate data on the internal and external structures of teeth combined with 3D printing to construct a tooth diagnostic model and pulp opening guide plate, we can accurately locate the position of the root canal and provide a new method for minimally invasive endodontics. At present, 3D printing technology is mainly used to guide the pulp opening pathway, assist in the minimally invasive treatment of malformed teeth and calcified root canals, and assist with apical surgery in the field of minimally invasive endodontics. However, its accuracy and clinical prognosis still need to be verified with a large number of clinical cases.

Application Practice to Determine Structure of UDI-PI in Implementation of UDI System / 中国医疗器械杂志

The purpose of UDI-PI and related international regulations/guidelines is analyzed. The application practice for the registrant/filing applicant to determine the composition of UDI is given. The article provides reference for the related stakeholders to implement UDI system.

Stability study and manufacture process optimization for Zhibai Anshen oral liquid / 药学实践杂志

Objective To optimize the manufacture process for Zhibai Anshen oral liquid. Methods The orthogonal designed experiments were conducted to monitor the effects of three factors on the content of mangiferin. The three factors included the amount of water, extraction time and alcohol precipitation concentration. Six month accelerated stability study and twelve month long term stability study were performed. Results Optimum percolation process was boiling the mixture with 10 times of water for 1 hour, followed by deposition with 60% alcohol. Conclusion This optimized process can be used for mass production.

Clinical application and research progress of digital complete denture / 华西口腔医学杂志

Digital technologies use high-precision three-dimensional scanning, intelligence-aided design software, and multi-axis numerical control milling or 3D printing, which can produce restorations with reliable precision and suitable function. However, the development of digital technologies in the field of complete denture restoration has been slow due to the complexity of prosthesis. This review article introduces the current research status and clinical applications of digital complete dentures in prosthodontic clinics and dental laboratories to provide beneficial references to prosthodontists and dental technicians.

Recent research progress in key technologies of Chinese materia medica manufacturing process quality control / 中草药

The development of Chinese materia medica (CMM) has risen to the level of national strategy. Under the new situation that the pharmaceutical industry implements the "Made in China 2025" strategy, quality control of the production process of CMM is one of the key areas in which the CMM industry needs to accelerate its breakthrough. The key common issues in process design, analysis and detection, process modeling, and manufacturing equipment and other aspects in the field of quality control of CMM production processes was analyzed in the paper. The progress in the three aspects of process understanding, real-time analysis method development and process control strategy establishment in the quality control system of CMM production process was reviewed. Combined with the author's corporate research practices, this paper introduces the application progress of key technologies such as quality by design (QbD), process analytical technology (PAT), experimental design (DOE), and multivariate statistical analysis in the above three research directions, and analyzes the difficulties problems in practical industrial application. The application prospect is prospected. The purpose of this article is to provide reference for CMM enterprises to apply and improve the quality control technology in the production process.

Principles and methods for selecting membrane separation process of Chinese materia medica based on “green manufacturing” concept / 中草药

The Chinese materia medica pharmaceutical process route designed for green manufacturing, also known as “green design”, aims to minimize the resource consumption and environmental effect of the life cycle of products process, coordinate and optimize economic and environmental efficiency. With membrane technology at the core of the pharmaceutical separation process technology closely related to green manufacturing of drugs. The three major requirements and maturity of “environment, performance, and cost” and separation technology principle are the basic elements of the pharmaceutical separation process green design. The development and adoption of clean technology not only conforms to the “principle of precautionary superior to governance”, but also reduces the consumption of raw materials and energy, and at the same time improves the economic efficiency of the enterprises. It is the best way to protect the coordinated development of the ecological environment and economic construction. In this paper, taking the construction of “membrane and resin technology system integration” as an example, the specific implementation plan for the green design of Chinese materia medica pharmaceutical process is introduced, and the technical economical problems in the design of pharmaceutical separation process are analyzed and discussed.

Studies on the methodology for quality control in Chinese medicine manufacturing process based on knowledge graph / 中国中药杂志

According to the requirements for developing the quality control technology in Chinese medicine( CM) manufacturing process and the practical scenarios in applying a new generation of artificial intelligence to CM industry,we present a method of constructing the knowledge graph( KG) for CM manufacture to solve key problems about quality control in CM manufacturing process.Based on the above,a " pharmaceutical industry brain" model for CM manufacture has been established. Further,we propose founding the KG-based methodology for quality control in CM manufacturing process,and briefly describe the design method,system architecture and main functions of the KG system. In this work,the KG for manufacturing Shuxuening Injection( SXNI) was developed as a demonstration study. The KG version 1. 0 platform for intelligent manufacturing SXNI has been built,which could realize technology leap of the quality control system in CM manufacturing process from perceptual intelligence to cognitive intelligence.

Intelligent and lean manufacturing for Chinese medicine:theory and its applications / 中国中药杂志

To cope with the " six major scientific problems" and the " five major technical challenges" of intelligent manufacturing and lean production of Chinese medicine( CM),we systematically proposed strategies,methods and the engineering theory of intelligent and lean manufacturing for CM by integrating the holistic view of traditional Chinese medicine and the concepts inspired from international advanced pharmaceutical technology. Moreover,the translational research of the theory and methods was successfully applied to six CMs such as Xuesaitong Injection. Several intelligent production lines were designed and built on the basis of the theory and methods,which greatly accelerated the digitalization,networking,and intelligence manufacture for CM. As a conclusion,the theory and applications provide technical demonstration for technical upgrading and high-quality development of CM industry.

Research progress, chemistry, manufacturing and controlsconsiderations of mesenchymal stem cell products / 药学学报

The number of clinical trials for mesenchymal stem cell (MSC) products ranked the top among all stem cell products, with more than 900 trials ongoing or completed by 2018. In China, many MSC clinical trials have started as "the third type of medical technique" and the dossiers of MSC products have been submitted to National Medical Products Administration (NMPA). The biological function and therapeutic effect of MSCs are constantly being recognized in scientific communities. However, the observed functions of MSCs in vitro are not fully reproduced in the living microenvironment in vivo. There are substantial variations among tissue origins, cellular phenotypes and biological functions. Different formulations, delivery methods, manufacture processes or doses all greatly affect the clinical efficacy. It is difficult for MSCs to maintain the naive state due to the differences between in vitro culture conditions and in vivo microenvironment. Meanwhile, there is no widely accepted scientific definition for MSCs until now, due to the complexity of manufacturing process and variable sources. Consequently, the regulation of MSC products is a challenge for drug administrative agencies. In this article, we review the research progress of MSC products around the world, and summarize the considerations in evaluating the chemistry, manufacturing and controls (CMC) section of MSC product applications, with respect to raw materials, manufacture processes and quality control. We hope that the information summarized here will provide insights for the development and evaluation of MSC products.

Effects of computer aided design and manufacture for reconstruction of mandibular defect with vascu-laried iliac crest flap graft / 中华医学美学美容杂志

Objective To evaluate the clinical application and effect of computerized digital sur -gical assisted design and manufacture for reconstruction of mandibular defect with vascularied iliac crest flap graft .Methods CT was used to scan the craniofacial and maxillofacial region of mandibular ameloblastoma patient ,and then the 3D model of the maxillofacial skeleton was reconstructed using the computerized digital surgical aid design to simulate the focal resection and the mandibular defect reconstruction with the iliac crest flap .Surgical guides were prepared by 3D printing to assist focal re-section and bone reshaping .Postoperatively ,clinical and CT examinations were performed to observe the restoration of the patient's facial appearance and occlusal relationship ,as well as wound healing and graft survival .Results Postoperative review results showed that the bone graft survived well ,and the anastomosed bone was formed .The wound in the surgery area healed .No recurrence of the tumor was found after clinical and CT examination .The maxillofacial appearance was well restored ,and the re-sidual occlusal relationship recovered well .Conclusions The use of computerized digital surgical aided design combined with 3D printing technology can effectively simplify the mandibular segmental defect repair and reconstruction and optimize the postoperative repair effect .

Application of digital technology in orthodontic clinic / 口腔疾病防治

@#The rapid development of digital technology has made the processes of orthodontic data collection, diagnosis, design and treatment more accurate, comprehensive, convenient and safe and has improved the clinical efficiency of orthodontists. Safe, non-invasive, rapid three-dimensional facial imaging and digital dental models have enabled orthodontists to collect accurately visualized case data. In addition, during diagnosis and design, orthodontists can comprehensively analyze teeth, jaws, and cranial surfaces in 3 dimensions. Through advances that range from digitized whole-dentition information to computer-replicated design and computer-aided manufacturing, invisible orthodontic technology without brackets has become one of the best manifestations of the combination of digital technology and oral orthodontics. In addition, individualized fixed orthodontic devices have become widely used in orthodontic clinics. In this paper, the applications of digital technology in orthodontic clinics is described. It is hoped that orthodontists will be able to use digital technology rationally to benefit increasing numbers of patients with orthodontic demands.

Energy Efficiency in the Food Industry: A Systematic Literature Review

Abstract Governments and private companies have increased efforts to identify effective actions for improving energy efficiency in manufacturing processes. The objective of this work is to improve the decision-making process by increasing the quality of information related to energy indicators in the food industry. This research involves developing a systematic literature review (SLR) to identify energy efficiency indicators in the food industry, which serve as inputs for a sectoral evaluation based on multicriteria techniques. The SLR identified six criteria evaluated by food industry experts, which form the proposed basis for evaluating the performance of related sectors. These criteria are: benchmarks, key performance indicators, framework, monitoring, ISO 50001, and information communication technologies (ICTs) in sectoral evaluations. The criteria were evaluated by experts using the Analytic Hierarchy Process (AHP), which prioritizes the most important food industry issues using an evaluation scale. Weights were attributed to each issue and positioned according to the Preference Ranking Organization Method for Enrichment Evaluations (PROMETHEE) to evaluate each sector by the identified criteria. The evaluated criteria are applicable to the three sectors surveyed, with emphasis on the beverage sector. Among the evaluated criteria, ICTs were highlighted by Industry 4.0 as a concern for the food sector.

A review of trade practices of smokeless tobacco products in terms of prohibition on sale, manufacturing & importation in Framework Convention on Tobacco Control ratified Parties

Background & objectives: Over the past decade, the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) has served as a powerful tool to initiate and advance global tobacco control efforts. However, the control strategies have mainly targeted demand-side measures. The goal of a tobacco-free world by 2040 cannot be achieved if the supply-side measures are not addressed. This analysis was undertaken to examine the tobacco control legislations of various Parties ratifying WHO FCTC with an objective to ascertain the status of prohibition of importation, sale and manufacturing of smokeless tobacco products. Methods: All 180 Parties to WHO FCTC were included for the study. A comprehensive database of all the parties to FCTC was created and tobacco control legislations and regulations of all parties were studied in detail. Results: Overall, the sale of smokeless tobacco (SLT) products was prohibited in 45 Parties. Eleven Parties prohibited manufacturing of SLT products and six Parties imposed a ban on importation of SLT products. Australia, Bhutan, Singapore and Sri Lanka banned all three. Interpretation & conclusions: Comprehensive tobacco control strategy with effective tobacco cessation programme should complement strong legal actions such as prohibition on trade in SLT products to meet the public health objective of such laws and regulations. In addition, multisectoral efforts are needed for effective implementation of such restrictions imposed by the governments.

Analysis on hearing status and related influencing factors in workers exposed to noise in an automobile manufacture enterprise / 中华劳动卫生职业病杂志

Objective@#To study the hearing status and analyze the related influencing factors in noise-exposed workers in an automobile manufacture enterprise, and put forward suggestions for prevention of noise-induced hearing loss.@*Methods@#Noise exposure level testing, audiometry testing and questionnaires were performed for noise exposed workers in the automobile manufacture enterprise. To analyze the relationship between different factors and noise-induced hearing loss by cumulative noise exposure(CNE) calculated 8-hour continuous A-weighted equivalent noise level and seniority.@*Results@#The detection rate of hearing loss in noise-exposed workers was 22.8%. The noise exposure intensity of stamping workshop is higher than other workshop, and the hearing loss detection rate of stamping workshop workers is higher than other workshop workers. The detection rate of hearing loss has significant difference in LAeq·8 h, seniority, CNE, age, high temperature and wearing earplugs (P<0.05). The results of logistic regression analysis showed that CNE, age and high-temperature were risk factors for noise-induced hearing loss (P<0.05 and OR>1) and there was an increasing tendency of hearing loss with increase in length of service and CNE, while using of earplugs was a protective factor (P<0.05 and OR<1). With the increase of CNE, the incidence of hearing loss is the rising trend.@*Conclusion@#It is suggested to strengthen the noise control and individual protection and improve the high-temperature working environment, which plays an important role in reducing the occurrence of noise-induced hearing loss.

Study on development and application of simple constraint mattress for child / 中国医学装备

Objective: To develop a child simple constraint mattress with good permeability,soft,comfort,safe and easily cleanable so as to effectively avoid accidents,such as falling from bed,bump injury,scratch and hurting others.Methods: 70 hospitalized children who need restrictive measures were randomly selected in this research and were divided into observation group(35 cases)and control group(35 cases)according to the time sequence of hospitalization.The constraint mattresses was used for children of observation group,and traditional constraint bands of wrist were used for children of control group.And the effectiveness,safety,comfort,convenience and parental satisfaction of the two constraint tools were observed.Results: The effectiveness,safety,comfort,convenience and satisfaction of constraint measure of observation group were significantly higher than those of control group(x2=10.27,x2=15.97,x2=19.09,x2=3.97,x2=15.88,P＜0.05).Conclusion: The constraint effect of simple constraint mattress is better than that of traditional constraint band of wrist.

Preface for special issue on synthetic biology (2017) / 生物工程学报

Synthetic biology has developed quickly over the past decade. To review the research progress in synthetic biology, we published this special issue that consists of three columns, namely scientific significance, technological advances, and applications in medical science, pharmaceutics, agriculture, material, environment and energy.

A strategy of constructing the technological system for quality control of Chinese medicine based on process control and management / 中国中药杂志

The current situation, bottleneck problems and severe challenges in quality control technology of Chinese Medicine (CM) are briefly described. It is presented to change the phenomenon related to the post-test as the main means and contempt for process control in drug regulation, reverse the situation of neglecting the development of process control and management technology for pharmaceutical manufacture and reconstruct the technological system for quality control of CM products. The regulation and technology system based on process control and management for controlling CM quality should be established to solve weighty realistic problems of CM industry from the root causes, including backwardness of quality control technology, weakness of quality risk control measures, poor reputation of product quality and so on. By this way, the obstacles from poor controllability of CM product quality could be broken. Concentrating on those difficult problems and weak links in the technical field of CM quality control, it is proposed to build CMC (Chemistry, Manufacturing and Controls) regulation for CM products with Chinese characteristics and promote the regulation international recognition as soon as possible. The CMC technical framework, which is clinical efficacy-oriented, manufacturing manner-centered and process control-focused, was designed. To address the clinical characteristics of traditional Chinese medicine (TCM) and the production feature of CM manufacture, it is suggested to establish quality control engineering for CM manufacturing by integrating pharmaceutical analysis, TCM chemistry, TCM pharmacology, pharmaceutical engineering, control engineering, management engineering and other disciplines. Further, a theoretical model of quality control engineering for CM manufacturing and the methodology of digital pharmaceutical engineering are proposed. A technology pathway for promoting CM standard and realizing the strategic goal of CM internationalization is elaborated.